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MDR/IVDR: Highly-anticipated guidance documents you should not be waiting for
20-10-2018

#MDR/IVDR: Highly-anticipated guidance documents you should not be waiting for

The transition time for the two Medical Device Regulations is rapidly ticking away: economic operators shall be fully compliant with the MDR by May 2020, and with the IVDR by May 2022. Are you an economic operator – in other words are you a Manufacturer, Authorized Representative, Importer, Distributor, System/Procedure Pack Assembler or Sterilization Service Provider? Then you might be eagerly waiting for further guidance (in the broadest sense of the word) from Europe. Here’s what guidance you can expect – and why you should not wait for it.


Roadmap for implementation

In November 2017, the Competent Authorities for Medical Devices (CAMD) issued a roadmap for implementation of the MDR/IVDR. CAMD identified seven technical areas/work streams and one over-arching/cross-cutting area/work stream. For each technical area/work stream, a list of actions items and priorities for various working groups was defined. This list outlines the roadmap for these working groups, according to which they can develop the guidance that you need for effectively implementing the MDR and the IVDR. Here’s what you can expect.

1. Clinical evaluation and clinical investigation (for Medical Devices); Performance evaluation and performance studies (for In Vitro Diagnostic Devices)

Expect guidance documents and/or Implementing Acts on the topics of equivalence, well-established technologies, clinical evidence and performance evaluation.  Several templates will be developed, such as templates for Summary of Safety and Clinical Performance, Clinical Investigation Application Form, SAE/device deficiency reports and timelines, PMCF Plan, and PMCF Report (and their IVD equivalents). For IVDs, new Common Specifications will be developed to replace the current Common Technical Specifications. Guidance regarding companion diagnostics is also to be expected.

2. Scope and classification

With the revised classification rules for MDs and IVDs, guidance will be developed around classification rules and scope.  Common Specifications are to be expected regarding Annex XVI products (products without an intended medical purpose). Implementing acts will be developed on the topic of reprocessing single-use devices.  Also, expect guidance on the appropriate level of interacting with relevant authorities regarding combination products and companion diagnostics.

3. Notified bodies and conformity assessment

These are specific for Notified Bodies and not for Economic Operators, however for Economic Operators it will be interesting to see the development of these guidance documents as they will give insight in, for example, the different routes for conformity assessment, the definition of ‘significant change’, or the differences between IVD Class B and C conformity assessment procedures.

4. Post-market surveillance and vigilance

New guidance will be developed on requirements for vigilance reporting. Also, various templates are going to be developed, such as a new Manufacturer Incident Report (MIR) Form, Field Safety Notice (FSN) and Periodic Safety Update Report (PSUR).
In addition, terminology might change as nomenclature for Adverse Events and Patient Harm will be (re)defined.

5. Eudamed and Unique Device Identification

According to the CAMD roadmap, expect clear and early instruction to stakeholders on how to interact with the system.  Guidelines will be developed on the topics of UDI assignment, UDI carriers, UDI marking and registration.

6. Market surveillance

CAMD is going to develop guidance or infographics for Economic Operators clarifying expectations around economic operator obligations, responsible person, liability, interaction with Eudamed and registration requirements.

7. IVD-specific issues

Specifically for IVDs, you can expect guidance on how to assess Class D IVDs in the absence of Common Specifications.
As already covered in previous work streams, also expect template documentation for performance studies, as well as guidance for assessment of companion diagnostics, classification, the appropriate level of interaction on combination products with relevant authorities, the nomenclature for Adverse Events and Patient Harm, and vigilance reporting.

8. Over-arching and cross-cutting priorities

Expect further definition of the responsibilities for conformity assessment of parallel importers and reprocessing of single-use devices. Also, guidance will be developed on the clarification of the role of the Medical Device Coordination Group (MDCG) in the governance of the regulations. Action items are defined to ensure that Eudamed will go live as planned (March 2020). As covered in the Eudamed work stream, instructions will be released to stakeholders on how to interact with the system. Current status is that functional specifications for Eudamed are to be released in May 2018, which implies that the progress towards the go-live date is still on track.

In January of this year, transitional provisions have been released by the CAMD Transition Sub Group, in the form of FAQs for both the MDR and the IVDR, covering initial questions on the topics of Eudamed, placing on the market of MDR/IVDR-compliant devices until date of application, placing on the market of MDD/AIMDD/IVDD-compliant devices after date of application, and the “sell off” provision in the MDR/IVDR. Keep an eye on these FAQs, as they are intended to evolve and expand over time.


Don’t wait, act now

Are you an economic operator waiting for guidance from Europe? Then there is little doubt that the expected guidance documents will be instrumental to you in implementing the requirements of the MDR/IVDR. These guidance documents may come in various sizes and shapes:

Delegated Act        Common Specification
Although not mentioned in the CAMD roadmap, Delegated Acts may be prepared and adopted by the European Commission. These non-legislative acts are based on, for example, specific objectives, content, scope, and duration that have been set out in the original legislative act (like the MDR or IVDR), and are considered to supplement or amend the original legislation. In other words, a Delegated Act tells us more about what actually is considered the law. The use of harmonized standards is good practice in order to presume to be in conformity with the General Safety and Performance Requirements. But in case relevant harmonized standards are considered not sufficient, or perhaps even not existing, the Commission may adopt Common Specifications which will have the same use as the harmonized standards. Specifically, regarding IVDs, current Common Technical Specifications may be replaced by such Common Specifications.
MEDDEV-like guidance documents
Designed as non-legally binding guidelines, MEDDEVs were intended to promote a common approach to be followed with regards to the three Medical Device Directives (MDD, AIMDD, and IVDD). As these Directives have been replaced by the MDR and IVDR, new MEDDEV-like guidance documents will be prepared to provide guidance with regards to the MDR/IVDR requirements. These may simply be updates of existing MEDDEVs, or may be entirely new guidance documents.
Implementing Act Other guidance documents
A non-legislative act that is considered to be procedural: a practical implementation of the rules that already exist in the original legislation, and thus may result in practical things such as templates, procedures, deadlines etcetera. In other words, an implementing act tells us how to implement the original legislation. These include any kind of (non-legally binding) guidance not covered by the above, such as infographics or FAQs.

But even though these guidance documents are highly-anticipated, here is why you should not wait for them – or more appropriately: why you should stop doing nothing while waiting for them.


Three reasons why time is running out:

  1. Although the preparation of a number of guidance documents, for example in the technical area of Clinical Evaluation, has been set to the highest priority, timing is the problem: as the CAMD roadmap does not define specific timelines for the release of the various guidance documents, it is not clear as to when exactly these guidance documents will be released – so chances are that it might be too late if you still have to start implementing.
  2. Judging from the CAMD roadmap, the amount of work ahead for the involved working groups and other stakeholders is substantial. For a number of the discussed guidance documents, it may even be a matter of years rather than months before they will be released. In the meanwhile, the date of implementation of the MDR and the IVDR is coming closer and closer, leaving you with hardly any time to become fully compliant with the regulations should you decide to wait.
  3. An additional obstacle is Brexit. Tough divorce negotiations between Brussels and London and the time-consuming work for MedTech experts involved in this topic will surely not help swift implementation of the CAMD roadmap and could cause serious delay in release dates. To add to that, historically the UK’s MHRA has played an important role within the European Union in developing policy aimed to protect public health as well as to support innovation in medical technology. If the MHRA steps out due to Brexit, this may add even more delay to release dates or adversely impact policy development.

Get time back on your side

It’s clear that the time that is left for you to get all the work done should not be underestimated. And the road ahead may be full of questions. You may find yourself at a crossroads now: should you sit and wait for guidance to arrive with the risk of having insufficient time left to become compliant, or should you get up and start transitioning already based on current knowledge with the risk of having to adjust once new guidance arrives?

Your best option is to start now and anticipate as best as you can on what is to come instead of wait and react. Start building a transition program based on what you can use from current guidance documents. As soon as new guidance documents are released, use these to double check to which extent you already comply with the MDR/IVDR, and to which extent you will have to fill any remaining gaps. This will get you further and will save you more time than doing nothing at all.

As we pointed out in our previous blog on MDR, time is running out fast: the longer you wait with the implementation of the MDR/IVDR requirements, the higher the risk will be that you will lose money.

Blog by: Urville Djasim – Consultant at Xendo


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